MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR HCV (AHCV); ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of nonreactive advia centaur hcv (ahcv) results which were discordant relative to patient history and alternate-method testing.Ahcv reagent lot 459 was in use at the time.Two patients produced nonreactive (negative) results in initial testing.The physician questioned these results based on patient history.The samples were re-tested in duplicate the following day, and both produced reactive (positive) results which were accepted as correct.Corrective reports were filed for both patients; the physician states that there was no patient impact.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of nonreactive advia centaur hcv (ahcv) results which werediscordant relative to patient history and alternate-method testing.The ahcv instructions for use (ifu) states the following, under interpretation of results: ¿results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.¿ the following is stated under limitations: ¿patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.¿ siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2024-00283 was initially reported on 2024-04-24.Update, april 2024: siemens has concluded the investigation.A customer from outside the united states reported observation of nonreactive advia centaur hcv (ahcv) results which were discordant relative to patient history and alternate-method testing.Quality control (qc) results were within expected ranges, and no issues were identified with any other samples.Additionally, internal test data show this reagent lot to be within specification, indicating that general reagent issues were not a likely cause.Service was performed on the affected instrument, including verifying probe positions and replacement of reagent compartment parts.Based on the available information, the cause of the discordant result cannot be definitively determined, but the issue may have been due to sample integrity issues or non-optimal instrument probe alignment.The customer is operational, and the reported issue was apparently resolved by routine service actions.No additional action is required.

• Brand Name: ADVIA CENTAUR HCV (AHCV)
• Common Device Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19040282
• Report Number: 1219913-2024-00283
• Device Sequence Number: 7241934
• Product Code: MZO
• UDI-Device Identifier: 00630414278759
• UDI-Public: 00630414278759
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2024
• Device Model Number: N/A
• Device Catalogue Number: 11203483
• Device Lot Number: 459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown